Impact of Massage Therapy and Music Therapy on the Quality of Life of Hospice Patients

NCT03217682 | Completed

• 1 other identifier: 17-002950
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a cohort study where subjects will receive either massage therapy or music therapy interventions to evaluate their impact on hospice patients.

Conditions

Pain; Anxiety; Depression; Quality of Life

Keywords

Hospice; Palliative Care; Integrative Medicine; Massage Therapy; Music Therapy; Caregivers

Outcome Measures

Primary Outcomes (1)

• Change in Edmonton Symptom Assessment System - Revised

  The primary endpoints are patient pain, depression, anxiety and wellbeing as measured by ESAS-r. Pro-rated area under the curve (AUC) statistics will be calculated for all individual items and total scores. The pro-rated AUC for ESAS-r measured pain, depression, anxiety, and wellbeing will all be utilized individually to assess the primary endpoint. The pro-rated AUC will be compared to the assessment score prior to any massage or music therapy. If there is any improvement, the therapy will be considered a success since any improvement will be seen as beneficial.

  Baseline to 3 weeks

Secondary Outcomes (4)

• Change in Edmonton Symptom Assessment System - Revised (Other symptoms)

  Baseline to 3 weeks

• Change in Linear Analogue Self Assessment (LASA)

  Baseline to 3 weeks

• Change in Patient Health Questionnaire for Depression and Anxiety (PHQ-4)

  Baseline to 3 weeks

• Change in Pearlin role overload measure (ROM)

  Baseline to 3 weeks

Study Arms (2)

Music Therapy

EXPERIMENTAL

Music therapy twice a week for two weeks, each session lasting approximately 45 min-1 hr

Other: Music Therapy

Massage Therapy

EXPERIMENTAL

Massage therapy twice a week for two weeks, each session lasting approximately 45 min-1 hr

Other: Massage Therapy

Interventions

Music Therapy OTHER

Music therapy sessions

Music Therapy

Massage Therapy OTHER

Massage therapy sessions

Massage Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is currently enrolled in Mayo Clinic Hospice
• Age 18 years or older
• ESAS-r scores of 5 or greater on pain, depression, anxiety, or best well-being (clinical assessment by hospice nursing staff)
• Patient or caregiver must be able to participate in brief interviews and complete questionnaires (verbally or physically)

You may not qualify if:

• Patients that would not be able to get a massage due to complexity of medical care including complex wound and multiple drains

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pain; Anxiety Disorders; Depression

Interventions

Music Therapy; Massage

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Therapy, Soft Tissue; Musculoskeletal Manipulations; Physical Therapy Modalities

Study Officials

• Maria Lapid, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: After the patient has been registered into the study, they will be assigned to either the music therapy or massage therapy cohort. The music therapy cohort will be available to the first 30 patients and 30 caregivers accrued. Upon reaching 60 subjects enrolled, the music therapy cohort will close to accrual and the massage therapy cohort will open to accrual. Once the massage therapy cohort has enrolled 30 patients and 30 caregivers, the massage therapy cohort will close to accrual and the study will be closed to all further accrual.

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 14, 2017
• Study Start: December 4, 2017
• Primary Completion: March 11, 2022
• Study Completion: March 11, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)